There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes.
Dr Pankaj Pasricha and associates from Maryland, USA, performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome.
The doctors conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months.
Patients were randomly assigned to groups given oral aprepitant or placebo.
The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-to-100 visual analog scale of nausea severity.
|Adverse events, predominantly mild or moderate in severity grade, were more common with aprepitant|
The research team calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis.
Aprepitant did not reduce symptoms of nausea, based on the primary outcome measure.
However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity for nausea, vomiting and overall symptoms.
The team observed that adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant.
In a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in visual analog scale score was used as the primary outcome.
However, aprepitant had varying effects on secondary outcomes of symptom improvement.
Dr Pasricha's team concludes, "These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant".